Arcutis Biotherapeutics (NASDAQ:ARQT) reported positive interim results from the INTEGUMENT-OLE long-term, open-label study of roflumilast cream 0.15% in adults and children ages six years and older with atopic dermatitis.
In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration. Efficacy was not only maintained but improved over time, with 46.1% and 51.0% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success.
Starting at week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD score of clear (0) switched to twice weekly maintenance dosing. Participants were to resume once-daily dosing if vIGA-AD reached mild (2) or if signs or symptoms were not adequately controlled. Over two-thirds of participants who switched to maintenance dosing remained on the twice weekly schedule for more than half of their time in the study post-week four.
“These results build upon the positive findings from the pivotal Phase 3 trials of roflumilast cream 0.15% in atopic dermatitis, demonstrating rapid efficacy within the first four weeks of treatment, and further validate the long-term durable efficacy and tolerability of roflumilast cream, with continued improvement over the course of the long-term study,” Eric Simpson, M.D., Professor of Dermatology at Oregon Health & Science University in Portland, Oregon, and INTEGUMENT trial investigator.
In addition, in the study, 61.5% and 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 demonstrated a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) after 28 weeks and 56 weeks, respectively.
The long-term study results reinforce the safety profile of roflumilast cream already seen in the short-term INTEGUMENT-1 and INTEGUMENT-2 clinical trials, with no new safety signals observed up to 56 weeks.
Arcutis intends to submit a supplemental New Drug Application late in the third quarter of 2023 for roflumilast cream 0.15% for the treatment of mild-to- moderate atopic dermatitis in individuals ages six years and older.
